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Flexion Biosciences, Inc.
Osteoarthritis pain
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Current therapies: either lubricant or have severe adverse effects
•HPA (hypothalamic-pituitary-adrenal) axis suppression and
hyperglycemia (GC: Kenalog)
•Lubricant (Hyaluronic acid): not much therapeutic effect
•Oral administration for knee pain (NSAIDs): GI and cardiovascular
adverse effects (AEs); have to use the lowest effective dose for the
shortest duration
•Take up to 7 days to work for arthritis pain (Motrin gel)
•Addictive (Opioids)
NSAIDs-induced small intestinal
damage
Problems of current therapies
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Our proposal having three folds of advantages
➢New product
•Dual (anti-inflammatory and analgesic) action: therapeutics
•No or minimal HPA/hyperglycemia: intra-articular injection
•Extended release: 3-month/injection
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The market > billions
➢Rheumatoid arthritis market size: $53.1b
(https://www.ihealthcareanalyst.com/global-rheumatoid-arthritis-drugs-market/)
➢Joint pain market size: >$5b in 2023; topical pain relief market $10.5b in 2023; and post operative
pain market $35.5b in 2022.
(https://www.polarismarketresearch.com/industry-analysis/joint-pain-injections-market)
https://www.precedenceresearch.com/joint-pain-injections-market
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IP patentable with practical de-risked strategies
➢Intellectual property (IP): ways to cover with patents
•Novel chemical entity (NCE)
•NCE with PLGA composites
•Production process (NCE and composite)
➢Strategies to approach
•Intra-articular injection to limit systemic AEs
•Prodrugs of current active drugs to lower the regulatory hurdle and de-risk development path
➢Competitive edges
•Safer vs available therapies
•Dual actions
•Longer therapy (3-month)
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New product expected to be dominant vs competitors
•Hyaluronic acid (HA): lubricant; possible CD44/RHAMM modulation and tissue
regeneration/angiogenesis factor: Triluron , and (Hyalectin®)
•Analgesic/anti-inflammatory NSAIDs: oral, GI adverse effects and cardiovascular issues:
Voltaren, Naproxen, Celecoxib, etc.
•Anti-inflammatory glucocorticoid steroids (GCs): oral and intra-articular: severe HPA axis
suppression and hyperglycemia: Kenalog® (triamcinolone acetonide) for injection;
Zilretta® (extended-release TCA/PLGA microspheres); Zilretta (TCA/PLGA): net sales
105.5m (2022), 111.1m (2023).
•Opioids: effective but generally controlled/limited use
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Fund to raise and one-year plans
➢Seeking pre-seed/seed:
➢$60k: make 5-8 proto compounds
➢$200k: confirm the dose reduction potential of the proto compounds in vivo
➢$800k: prepare sustained release form and analyze blood drug concentration for HPA axis
suppression and hyperglycemia in animal model, efficacy and non-GLP tox.
Main tasks
\month, 2024 6 7 8 9 10 11 12 1/25 2 3 4 5
Proto 5
-8 compounds synthesis: $60k
Assay set
-up and evaluation of stability, and biomarker:
$200k
Complete knee and blood PK: $200k
Microparticle prep
, and encapsulation and PK: $200k
$200k
Optimization of ratio, linker: $200k
In vivo efficacy: $200k
Non
-GLP tox: $200k
Project review
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Project questions answered
1: Is the product much better than the existing products?
•The product will be the best osteoarthritis pain therapy: efficacious, safer (with minimal HPA
axis suppression and hyperglycemia, etc.) and long action.
2: Can you find and market the product to the users of the product?
•About 21.2% of all adults, or 53.2m people in US, have arthritis. Market size is >billions.
3: Is the market growing?
•According to multiple sources, CABG at high digit %.
4: Is the product defendable?
•Yes, new NCE. Patent has been drafted.
5: Can you get the team, knowledge and capital to build the product?
•Yes, the path has been paved, but it may require $40-50m to go through clinical phases 1-2a
for IPO.
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SWOT analysis
➢Strengths（S）
oValidated biology, SAR clear, and markets, known regulatory path, product profile superior vs
competitors.
➢Weaknesses（W）
oStart late, no commercial team
➢Opportunities（O）
oBest product in huge market will have a dominant share
oFuture IPO/licensing
oLow risk
➢Threats（T）
oNo sufficient fund for IND, IPO, or phase 2a-3.
Palo Alto, CA
